It became evident in the 2001 consort revision that explanation and elaboration of the principles laid down in the statement would further help the investigators and the authors. Consort 2010 checklist randomised trials pdf ms word. We strongly recommend reading this statement in conjunction with the consort 2010 explanation and elaboration for important clarifications on all the items. Consort statement and its accompanying explanation and elaboration document. Ten consort items have been modified, and examples of good reporting and an. Consortspi 2018 extends 9 items 14 including subitems from the consort 2010 checklist, adds a new item with 3 subitems related to stakeholder involvement in trials, and modifies the consort 2010 flow diagram. The main product of the consort group is the consort statement, which is an evidencebased, minimum set of recommendations for reporting randomized trials. Mar 24, 2010 the consort 2010 explanation and elaboration. Consort 2010 flow diagram randomised trials pdf ms word. The consort 2010 explanation and elaboration provides elucidation and context to the checklist items. Changes in consort 2010 the revision process resulted in evolutionary, not revo. Consort 2010 checklist of information to include when reporting a randomized triala section and topic item no. This extension of the consort 2010 statement, a guideline and checklist for reporting parallel group randomized trials, provides updates for the reporting of multiarm trials to assist evaluations of rigor and reproducibility and enhance understanding of the methodology of trials with more than 2. Furthermore, to achieve the aim of widest possible dissemination and adoption of consort, the 2010 consort guidelines were copublished in eleven journals, including plos medicine and lancet.
We have developed an extension to the consort 2010 statement for social. The explanation and elaboration document was therefore published along with the 2001 version of the consort statement. Consort revision, it became clear that explanation and elaboration of the principles underlying the consort statement would help investigators and others to write or appraise trial reports. After an expert meet ing in janua ry 20 07, the consort statement has. Consort 2010 checklist of information to include when reporting a. Schulz kf, altman dg, moher d, for the consort group. A consort explanation and elaboration article was published in 2001 alongside the 2001 version of the consort statement. Updated guidelines for reporting parallel group randomised trials david moher, sally hopewell, kenneth f. Along with the consort statement, we have updated the explanation and elaboration article, which explains the inclusion of each checklist. The updated explanation and elaboration manuscript was distributed to the entire group for additions, deletions, and changes. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Tidier checklist intervention description and replication pdf.
The consort explanation and elaboration article 58 was published in 2001. Devereaux, diana elbourne, matthias egger, douglas g. Changes in consort 2010 the revision process resulted in evolutionary, not revolutionary. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the consort statement. Explanation and elaboration document for the strobevet statement. We strongly recommend using the explanation and elaboration in conjunction with the checklist to foster complete, clear, and transparent reporting and aid appraisal of published trial reports.
Altmand bern, switzerland, corfu, greece, london and oxford, united kingdom, and paris, france highquality randomized controlled trials rcts are an integral part of evidencebased medicine. The revised checklist is shown in table 1 and the flow diagram, not revised, in fig 1. After an expert meeting in january 2007, the consort statement has been further revised and is. Apr 17, 2001 this explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the consort statement. After an expert meeting in january 2007, the consort statement has been further revised and is published as the consort 2010 statement. The most recent version of the statementthe consort 2010 statementconsists of a 25item checklist and a participant flow diagram, along with some brief descriptive text.
Consort 2010 checklist of information to include when reporting a randomized triala. We have made several substantive and some cosmetic changes to this version of the consort explanatory document full details are highlighted in the 2010 version of the consort statement59. Consort 2010 checklist of information to include when. If relevant, we also recommend reading consort extensions for cluster randomised trials, noninferiority and equivalence trials, nonpharmacological treatments, herbal interventions, and.
Application within and adaptations for orthodontic trials nikolaos pandis,a padhraig s. Extension of the consort 2010 statement with explanation and elaboration k hemming 1, m taljaard 2, je mckenzie 3, r hooper 4, a copas 5, ja thompson 5 6, m dixonwoods 7, a aldcroft 8, a. Reporting of multiarm parallelgroup randomized trials. Altmand bern, switzerland, corfu, greece, london and oxford, united kingdom, and paris, france. Consort spi 2018 extends 9 items 14 including subitems from the consort 2010 checklist, adds a new item with 3 subitems related to stakeholder involvement in trials, and modifies the consort 2010 flow diagram. We have made several substantive and some cosmetic changes to this version of the consort explanatory document full details are highlighted in the 2010 version of the consort statement. Consolidated standards of reporting trials wikipedia. That final iterative process converged to the consort 2010 explanation and elaboration. Reporting of steppedwedge cluster randomised trials. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and.
Jun 01, 2010 the consort 2010 explanation and elaboration provides elucidation and context to the checklist items. The revised consort statement for reporting randomized trials. Sep 29, 2011 consort 2010 explanation and elaboration. During the 2001 consort revision, it became clear that explanation and elaboration of the principles underlying the consort statement would help investigators and others to write or appraise trial reports. If relevant, we also recommend reading consort extensions for cluster randomised trials, noninferiority and equivalence trials, nonpharmacological.
Translations of reporting guidelines the equator network. Extension of the consort and spirit statements the lancet. Title and abstract 1a identification as a randomized trial in the title 1b structured summary of trial design, methods, results, and conclusions for specific guidance see. Mar 24, 2010 the consort 2010 explanation and elaboration provides elucidation and context to the checklist items. The revised consort statement for reporting randomized. Updated guidelines for reporting parallel group randomised trials. Aug 28, 2014 consort 2010 explanation and elaboration bmj 1. In addition, a detailed 28page explanation and elaboration article was published in three journals, including british medical journal, and is a must. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted. Moher d, hopewell s, schulz kf, montori v, gotzsche pc, devereaux pj, elbourne d, egger m, altman dg, for the consort group. Original article explanation and elaboration document for. The consort explanation and elaboration article 58 was published in 2001 alongside.